FuRST 2.0 Cognitive Pre-testing - Round 2

CHDI Foundation, Inc.

Status

Completed

Conditions

Huntington Disease

Treatments

Behavioral: FuRST 2.0

Study type

Observational

Funder types

Other

Identifiers

NCT03709173

C-000918-3

Details and patient eligibility

About

The study is a single, cross-sectional cognitive interview of FuRST 2.0, functional rating scale, administered to forty Huntington's Disease Gene Expansion Carriers (HDGECs) and potentially, their companions (the companion's participation is optional in this study). The scale will be tested as a patient reported outcome (PRO) in that the information will come directly from the HDGEC participant or the HDGEC participant together with his/her companion through self-report. The purpose is to identify real or potential comprehension or usage problems with scale items, response options, instructions and disclaimer statement, which are all components of the FuRST 2.0 scale. Through a structured cognitive interview with the HDGEC participants or the HDGEC participants together with their companions, followed by qualitative analysis, the final phrasing of the individual scale items, response options, instructions and disclaimer statement for the scale will be generated. Depending on the results of this study, an additional round of cognitive pre-testing may be required in a separate study.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Premanifest HDGECs:

Identified as an active participant in Enroll-HD (participants who have completed their last onsite Enroll-HD visit within approximately 15 months)
At least 18 years of age
Fluent in English and had his/her primary education in English
Able and willing to provide critical feedback (per site PI or site PI's designee discretion)
Willing and able to provide written informed consent
Cytosine, Adenine, Guanine (CAG) length ≥ 40
Disease burden score (DBS) ≥ 250
Diagnostic confidence level (DCL) ≤ 3

Inclusion Criteria for Early-manifest HDGECs:

Identified as an active participant in Enroll-HD (participants who have completed their last onsite Enroll-HD visit within approximately 15 months)
At least 18 years of age
Fluent in English and had his/her primary education in English
Able and willing to provide critical feedback (per site PI or site PI's designee discretion)
Willing and able to provide written informed consent
CAG length ≥ 36
DCL= 4
Total Functional Capacity (TFC) ≥11

Inclusion Criteria for a Companion of an HDGEC

At least 18 years of age
Fluent in English and had his/her primary education in English
In his/her opinion, has sufficient interaction and knowledge of the HDGEC participant's capabilities and daily activities
Is acceptable to the HDGEC participant and the site PI or site PI's designee
Willing and able to provide written informed consent

Exclusion Criteria for an HDGEC/a companion of HDGEC: